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NIVESTYM™ (filgrastim-aafi) Description

11 DESCRIPTION

Filgrastim-aafi is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology.

NIVESTYM is produced by Escherichia coli (E coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. NIVESTYM has a molecular weight of 18‚799 daltons. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis‚ except for the addition of an N-terminal methionine necessary for expression in E coli. Because NIVESTYM is produced in E coli‚ the product is non-glycosylated and thus differs from G-CSF isolated from a human cell.

NIVESTYM is a sterile‚ clear‚ colorless‚ preservative-free liquid containing filgrastim-aafi injection for subcutaneous or intravenous use. The product is available in single-dose vials and prefilled syringes. The single-dose vials contain either 300 mcg/mL or 480 mcg/1.6 mL of filgrastim-aafi. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim-aafi. See Table 4 below for product composition of each single-dose vial or prefilled syringe.

Table 4. Product Composition
300mcg/mL Vial480 mcg/1.6 mL Vial300 mcg/0.5 mL Syringe480 mcg/0.8 mL Syringe
*
quantity sufficient to make
Filgrastim-aafi300 mcg480 mcg300 mcg480 mcg
Acetate0.59 mg0.94 mg0.295 mg0.472 mg
Polysorbate 800.04 mg0.064 mg0.02 mg0.032 mg
Sodium0.035 mg0.056 mg0.0175 mg0.028 mg
Sorbitol50 mg80 mg25 mg40 mg
Water for Injection USP
q.s. ad*
1 mL1.6 mL0.5 mL0.8 mL

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